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Initiation Clinical Research Associate I / Study Start-Up Specialist

Spain - Any Region - Home Based Date posted 10/16/2020 Job ID 63604BR

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.

As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent
  • "The last 4.5 years I had a steep learning curve and I am still learning via on-the-job challenges and solid management feedback. Next to my personal growth, I also enjoy our open atmosphere and the great collegiality."

    Stefanie – Sr Clinical Research Associate

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

This position is a 6 months contract

The main responsibility of the
Initiation Clinical Research Associate (iCRA) is to conduct and facilitate specific start-up activities such as feasibility, site identification, pre- qualification, Site Regulatory Package (SRP) review and approval, Informed Consent (ICF) customization, IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.


Key Accountabilities:

• Conduct country specific feasibility and/or site pre-qualification.
• Review and validate site identification list.
• Collect and negotiate Confidentially Agreements (CDA) as required.
• Organize translations per country/regulatory/client requirements.
• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP).
• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments.
• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments).
• Prepare and negotiate as required initial and/or amended CSA at a site level.
• Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required.
• Collect internal CSA signatures.
• Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.).
• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity).
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training.
• Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery.
• Update all appropriate Clinical Trial Management Systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan.
• Escalate any site and study issues that require immediate action to the Functional Lead (FL).
• Proactively work with other project team members to meet project goals.
• Show commitment and perform consistent high quality work.

Qualifications

xSkills:

• Client focused approach to work.
• Ability to interact professionally with external customers.
• Ability to manage multiple and varied tasks with enthusiasm.
• Attention to detail.
• Willingness to work in a matrix and virtual team environment and to value the importance of teamwork.
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic .Document Management System (EDMS), and MS- Office products such as Excel and Word.
• Sound interpersonal, verbal, and written communication skills.
• Sound problem solving skills.
• Sense of urgency in completing assigned tasks.
• Effective time management in order to meet daily metrics, team objectives, and department goals.
• Developing ability to work across cultures.
• Ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs.
• Willing and able to travel locally and internationally occasionally as required.

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred).

Language Skills:

• Proficient in written and oral English and Spanish languages.

Minimum Work Experience:

• Previous documented relevant work experience in clinical research (Site Management experience, Start Up experience).


If you are ready to join PAREXEL’s Journey, please apply!

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